Briana Contreras

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ICER came out with a report a month ago on two cholesterol-reducing agents that may compete with the PCSK9 inhibitors, according to Steven D. Pearson, M.D., M.Sc., founder and president of ICER, said in a recent interview with 

Pearson warned about repeating the mistakes of the past and those early high-priced, low-uptake years of Praluent and Repatha. 

“We all should just be aware that price and access are joined at the hip,” Pearson told 

. “It did feel that the first few years after the PCSK9 inhibitors came out, there was an opportunity squandered because of all the friction and the difficulty that patients and doctors had. And certainly the companies felt like the uptake of the PCSK9 inhibitors — and their revenues — weren’t good.”

The two drugs assessed in the ICER report are bempedoic acid and inclisiran. Bempedoic is sold as Nexletol and, in combination with ezetimibe, as Nexlizet. The FDA held up approval of inclisiran after it found manufacturing problems at a plant in Italy, where the drug is made. ICER says its cost-effectiveness math shows that a fair annual price for the bempedoic acid/ezetimibe combination would be between $1,600 and $2,600, which would be 36% to 60% less than the current wholesale acquisition. ICER’s cost-effectiveness math for inclisiran, which doesn’t have a price yet because it is not the market, put the price tag between $3,600 and $6,000. Pearson said the PCSK9 inhibitors were a hard lesson learned about the dynamics of pricing and squandering the opportunity to bring innovative drugs into clinical use. “If we can get the prices aligned at the front end, that just gets the ball rolling in the right direction.”

Whether inclisiran will be considered to be in the same class as the PCSK9 inhibitors could be a complicating factor in the drug’s uptake. It has a different mechanism of action but does work in the same biochemical pathway, noted Pearson: “A clinician would tell you that it serves the same purpose.” One possible advantage of inclisiran is that it needs to be administered only twice a year, albeit by a healthcare professional, in contrast with the once- or twice-monthly self-administered injections of Praluent and Repatha. A clinician with experience in underserved communities commented at an ICER meeting that the less frequent dosing, administered in a doctor’s office, would be an advantage for many of the patients he cares for, Pearson said.

If and when someone writes the history of drug pricing in the U.S., the cholesterol-lowering PCSK9 inhibitors are likely to be a paradigmatic chapter. When Repatha (evolocumab) and Praluent (alirocumab) came on the market in 2015, their list prices were more than $14,000 a year. But expectations of wide use and big sales crashed and burned. Payers and, to some extent, physicians bridled at the price of the new drugs, which are administered by self-injection. The Institute for Clinical and Economic Review (ICER), the cost-effectiveness research organization in Boston, had already made a name for itself in the controversy about the pricing of the hepatitis C antivirals. It weighed in with a cost-effectiveness assessment that said the prices of the PCSK9 inhibitors should be slashed by 60% or more.

“I think it actually just affirmed what many payers and others were feeling, which was that this seemed like an expensive drug for the clinical value that it was going to provide for the average patient,” Pearson said.

“What was unique about them (the PCSK9 inhibitors) was that they were a completely new paradigm of care for patients with high cholesterol,” Pearson continued

 “There are obviously a lot of patients in the country who had high cholesterol despite using the available pills, so the potential for the budget impact was so high that it caught a lot of people’s attention.”

Starting in 2018, Sanofi and Regeneron, the manufacturers of Praluent, and Amgen, which makes Repatha, started to compete on price, and by 2019, the annual price tags of their PCSK9 inhibitors were below $6,000, still more expensive than the price ranges recommended by ICER (which has revised them since 2015 as new study results have been reported) but still half of the initial price. In a February earnings report, Amgen stated that sales revenue from Repatha increased by 34% in 2020 compared with 2019, with a 67% increase in volume largely responsible for the uptick. At about the same time, Sanofi reported that sales of Praluent increased by 2.3% in 2020.

So arguably a tick in the win column for tying drug prices to cost-effectiveness — and for ICER — right?

Articles

In this new episode of MHE Talks: Improving Patient Access podcast, Steven D. Pearson, M.D., M.Sc., warns that high prices can squander an opportunity to bring innovative medications into clinical use. 


ICER Chief on Bempedoic Acid and Inclisiran: Don’t Repeat the PCSK9 Mistake

More than a half million Americans have taken advantage of the Biden administration’s new health insurance keyed to the COVID-19 pandemic.

According to the government, even more consumers will gain coverage in the coming months.

Officials expect sign-ups to keep growing because millions of people became eligible effective Apr. 1 for 

 toward their premiums under President Joe Biden’s coronavirus relief legislation. In addition, the Congressional Budget Office estimates about 3 million people lost coverage as a result of the pandemic, while some private experts estimate higher numbers in the range of 5 to 10 million. 

The special sign-up opportunity for Affordable Care Act plans will be available until Aug. 15.

Biden campaigned and is now building on the Obama-era health law to push the United States toward coverage for all. 

With the number of uninsured Americans rising during the pandemic, Biden reopened the law’s heath insurance markets as a backstop. Then, the virus aid package essentially delivered a health insurance price cut by making taxpayer subsidies more generous, while also allowing more people to qualify for financial assistance.

These aids are available the rest of this year and through the end of 2022. Consumers who were already covered by the health law at the beginning of this year are also entitled to the increased financial aid, but will have to go online or call to update their plan. People on average could save $50 a month, the government says.

 released Wednesday by the Centers for Medicare and Medicaid Services show that 528,005 people newly signed up for government-sponsored private plans from Feb. 15 to Mar. 31.

Republicans say expanding the health law is the wrong way to go, but Waqaas Al-Siddiq, PhD, founder and CEO of 

, a medical diagnostic and consumer healthcare technology company, shares insights on the importance of coverage expansion.

“Coverage expansion is the right direction for healthcare in the US," Al-Siddiq said. "We are already in a semi public/private system as CMS is the largest insurer which is essentially public coverage administered through private providers. The broader issue is still a need to address the costs associated with administration. If we can tackle that, the cost of expanded coverage would be significantly less as a result of cost savings by reduction of unnecessary admin layers.”

He also shared what this coverage means for the healthcare landscape in the U.S. and what it means for telemedicine.

“Coverage means the healthcare market will increase, emergency visits and expenses should come down, and hopefully premiums will come down," he added. "There are broader issues to impact the latter but there are many steps required to optimize the US healthcare system.”

For now, telemedicine will be expanded because guidelines and coverage as a result of covid are still in place, Al-Siddiq said. 

"What happens to telemedicine after covid or once these guidelines get close to expiration remains to be seen. I suspect they will become standardized as the value of telemedicine has become quite clear.”

More than a half million Americans have taken advantage of the Biden administration’s new health insurance keyed to the COVID-19 pandemic.









More Than Half a Million Americans to Gain Health Coverage

Below is a short Q&A of the interview with Shiela:


Q: What advice do you give aspiring young, Black, or minority healthcare professionals who seek to work at an executive level?

 I would coach them to try to get support in their respective organizations, from what I would call a mentor, as well as a sponsor. Those are two different things. A mentor is someone that you know, you can go to, for advice on how you could want to show up in a meeting, prepare for the meeting, or prepare your career to have other experiences. But a sponsor or someone who's sitting in the meeting room, and when the discussions are being had about whether or not an individual should be considered for a new role or promotion. The sponsor is a person that's in the room that's willing to put their own personal reputation on the line to advocate for an individual to be promoted to be given a broader responsibilities. 

Videos

In this final video of three-part video interview series, MHE spoke with founder and CEO of Gray Matter Analytics. In the discussion, Sheila addressed the topic of how healthcare organizations are missing out by not actively expanding their efforts to seek out and fast track talented individuals across many minority populations, especially in the c-suite.

Advice for Aspiring Minority Healthcare Professionals Who Seek C-Suite Positions

Below is an excerpt Q&A of the interview with Ami:

 Can you share what the rise of the chief medical officer role has been in the C-suite?

 So most healthcare companies already had chief medical officers. If you think about their role, it's really to inform the operations or the strategy for the healthcare company to grow in whatever space it was in. But with COVID, every chief medical officer in the country suddenly also had to become an epidemiologist, a workplace safety expert, and really inform the business strategy for the company.

While we always knew where you work and how you worked affected your health, and your health affected how you show up to work, I think the pandemic really shone a light on that. For the first time, it was explicitly clear that if you weren't taking care of employees and their dependents safety and health, you weren't going to be able to meet your business objectives. Similarly, people expected to hear from their employers about their health and safety and workplace safety.

So the role of the chief medical officer, specifically, really shifted from being focused on the goals of the healthcare organization to becoming a business strategy role of "How do we stay open?" "How do we keep our employees safe?" How do we get them back to work now?" "How do we think about vaccinations?" All of these questions that are integral to our economy getting back on track, became part of the role of the chief medical officer.

 How can businesses benefit from the CMO role and what does this role mean for the future of the C-suite?

 One of the great things we've been able to do at Grand Rounds, because we have so many strong clinicians on our team here, is actually offer virtual chief medical officer roles for some of our customers. These are customers who didn't have a chief medical officer prior because they're probably not in the healthcare space, but realized how critical that insight that clinical expertise would be for their business strategy.

We were able to talk to their C-suite about how we should think about thresholds for sending people to work from home, how we should think about the prevalence in the community in which we operate. How should we think about behavioral health these days when so many people are struggling with anxiety and depression at record levels?

What we've noticed is for companies who aren't in healthcare naturally, but who needed that sort of insight in their C-suite, is this virtual CMO was one way for us to help them think through all the implications of the pandemic for their populations.

In this second video of a two-part video series, MHE spoke with Dr. Ami Parekh, chief medical officer of Grand Rounds. Ami discussed the rise of the chief medical officer role, how businesses can benefit from it and what it means for the future of the C-suite. She also explained why it is so essential for businesses to provide advice and clinical guidance to help best keep operations running safely.


Briana Contreras

Articles

ICER Chief on Bempedoic Acid and Inclisiran: Don’t Repeat the PCSK9 Mistake

More Than Half a Million Americans to Gain Health Coverage

Advice for Aspiring Minority Healthcare Professionals Who Seek C-Suite Positions

The Importance of Providing Guidance for Businesses Through the CMO Role